Effect of Boswellia Sacra as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction

NCT ID: NCT05820646

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-08-31

Brief Summary

This research will study the effect of Boswellia Sacra versus calcium hydroxide as an intracanal medicament on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in mandibular premolars with necrotic pulp.

Detailed Description

Primary outcome Postoperative pain measured using numerical rating scale (NRS)

1. After placement of intracanal medicament at 6, 12, 24 and 48 hours.

2. After root canal obturation at 6, 12, 24 and 48 hours.

Secondary outcomes Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) .

1. Sample 1 (S1): after access preparation and pre-instrumentation.

2. Sample 2 (S2): post-instrumentation.

3. Sample 3 (S3): post-intracanal medicament removal at 3 or 7 days according to the group.

Conditions

Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients with necrotic mandibular premolars will be treated with boswellia sacra

25-45 years old patients with necrotic single rooted mandibular premolar with single canal with periapical lesion will be treated with boswellia sacra as an intracanal medicament for 3 days

Group Type: EXPERIMENTAL

Boswellia Sacra

Intervention Type: OTHER

1. Boswellia Sacra used as an intracanal medicament for 3 days

2. Boswellia Sacra used as an intracanal medicament for 7 days

Patient with necrotic mandibular premolar will be treated with boswellia sacra

25-45 years old patients with necrotic single rooted mandibular premolar with single canal with periapical lesion will be treated with boswellia sacra as an intracanal medicament for 7 days

Group Type: EXPERIMENTAL

Boswellia Sacra

Intervention Type: OTHER

1. Boswellia Sacra used as an intracanal medicament for 3 days

2. Boswellia Sacra used as an intracanal medicament for 7 days

Patients with necrotic mandibular premolar will be treated with calcium hydroxide

25-45 years old patients with necrotic single rooted mandibular premolar with single canal with periapical lesion will be treated with calcium hydroxide as an intracanal medicament for 7 days

Group Type: ACTIVE_COMPARATOR

Boswellia Sacra

Intervention Type: OTHER

1. Boswellia Sacra used as an intracanal medicament for 3 days

2. Boswellia Sacra used as an intracanal medicament for 7 days

Interventions

Boswellia Sacra

1. Boswellia Sacra used as an intracanal medicament for 3 days

2. Boswellia Sacra used as an intracanal medicament for 7 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age between 25-45 years old.

2. Males or females.

3. Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)

4. Patients' accepting to participate in the trial.

5. Patients who can understand pain scale and can sign the informed consent.

6. Mandibular Single rooted premolars, having single root canal:

• Diagnosed clinically with pulp necrosis.
• Absence of spontaneous pulpal pain.
• Positive pain on percussion denoting apical periodontitis.
• Periapical radiolucency not exceeding 2*2 mm radiographically.
• Normal occlusal contact with opposing teeth.

Exclusion Criteria

1. Medically compromised patients having significant systemic disorders (ASA III or IV).

2. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.

3. Pregnant women: to avoid radiation exposure, anesthesia, medication and hormonal Fluctuation that might increase pain prevalence.

4. Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation.

5. Patients with two or more adjacent teeth requiring endodontic treatment.

6. Teeth that requires further procedural steps or multidisciplinary approach, which is out of this experiment's scope:

i. Association with swelling or fistulous tract. ii. Acute periapical abscess. iii. Mobility Grade II or III. iv. Pocket depth more than 5mm. v. Previous root canal treatment. vi. Non -restorable vii. Immature roots viii. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.

7. Inability to perceive the given instructions.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Helmy Abd-Elghafar Abo Kashwa

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa A. El.Baz

Role: STUDY_DIRECTOR

Professor

Locations

Cairo University Hospital ,Endodontic clinic

Giza, Manial, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Aya H. Abo Kashwa, Masters

Role: CONTACT

aya.abokashwa@dentistry.cu.edu.eg

01021547230

Radwa S. Emara, PhD

Role: CONTACT

radwa.emara@dentistry.cu.edu.eg

01272141312

Facility Contacts

Aya H. Abo Kashwa, Masters

Role: primary

aya.abokashwa@dentistry.cu.edu.eg

01021547230

Radwa S. Emara, PhD

Role: backup

radwa.emara@dentistry.cu.edu.eg

01272141312

Other Identifiers

ENDO 3.7.1

Identifier Type: -

Identifier Source: org_study_id